Drug control protocol in India

  • September 19, 2022
  • Posted by: OptimizeIAS Team
  • Category: DPN Topics
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Drug control protocol in India

Subject :Government Schemes

Context:

The Union Health Ministry recently released the new National List of Essential Medicine (NLEM)-2022, revising it after a seven-year period.

Concept:

National List of Essential Medicine (NLEM)-2022:

  • It is based on the World Health Organisation’s essential medicine list.
  • India’s first list was developed in 1996.
  • It has since been modified four times – in 2003, 2011, 2015, and now in 2022.
    • It is revised due to the changing profile of diseases in the country, invention of newer drugs, drugs becoming obsolete or being banned for certain risks, and newer treatment protocols.

Importance: 

  • The list creates a framework for procurement of medicines at government healthcare facilities.
    • NLEM marks all drugs as P, S, or T depending on whether they ought to be available at primary, secondary or tertiary healthcare facilities.
  • It also helps hospitals create their drug policies such as which medicines to be used.
  • Guide safe and effective treatment of priority disease conditions of a population.
  • Promote the rational use of medicines.
  • It can also be a guiding document for the State governments to prepare their list of essential medicines

Drug control protocol in India:

  • The government has the power to control the prices of certain medicines, those needed in public interest, through the Drug Prices Control Order. 
  • The National List of Essential Medicines forms the primary basis for considering a drug as essential and controlling its prices.
    • The National List of Essential Medicines (NLEM) is a list released by the Ministry of Health and Family Welfare, following which the Department of Pharmaceuticals incorporates them into Schedule 1 of DPCO.
    • The medicines listed in the NLEM are sold below a price ceiling fixed by the National Pharmaceutical Pricing Authority (NPPA).
      • NPPA was constituted by the Government of India in 1997 as an attached office of the Department of Pharmaceuticals (DoP), Ministry of Chemicals & Fertilizers as an independent Regulator for pricing of drugs and to ensure availability and accessibility of medicines at affordable prices.
      • It was made to fix/revise prices of controlled bulk drugs and formulations and to enforce price and availability of the medicines in the country, under the Drugs (Prices Control) Order, 1995-2013 (DPCO).
    • The prices of medicines under the NLEM cannot be increased by the companies themselves, but every year the prices are increased or decreased as per the Wholesale Price Index.
  • Additionally, the prices of drugs other than those included in the NLEM may also be controlled through the DPCO.
    • Under the provisions of Drug Prices Control Order, DPCO 2013, only the prices of drugs that figure in the National List of Essential Medicines (NLEM) are monitored and controlled by the regulator, the National Pharmaceutical Pricing Authority.
    • Paragraph 19 of the DPCO, 2013, deals with increase or decrease in drug prices under extraordinary circumstances. However, there is neither a precedent nor any formula prescribed for upward revision of ceiling prices
Background: 

  • The first country in the world to compose its EML was Tanzania in 1970. 
  • In 1975, the World Health Assembly (WHA) requested WHO to assist member states in selecting and procuring essential medicines, assuring good quality at a reasonable cost.
    • Subsequently, the first WHO model list of essential medicines was published in the year 1977 which contained 186 medicines.
Drug control protocol in India Government Schemes